SpinChip Hs-cTnI Determination of the 99th Percentile URL

NCT06463275 | Completed

• 2 other identifiers: Design Protocol-03542CIV-SE-23-12-045358
• Study Type: observational
• Target: 1,355
• Locations: 1 country
• Sites: 4

Brief Summary

During a heart attack, the protein troponin I is released from the heart muscle into the bloodstream. Measurements of cardiac troponin in blood are used as an aid in the diagnosis of heart attack. Low levels of troponin are also present in the blood stream of healthy individuals and can be detected by high-sensitive troponin tests. The SpinChip hs-cTnI test is a new high-sensitive test for measuring the amount of cardiac troponin I in the bloodstream as an aid in the diagnosis of heart attack. The purpose of this study is to determine the upper reference limits (URLs) for the SpinChip hs-cTnI test in a healthy population.

Conditions

Acute Myocardial Infarction

Keywords

Acute Myocardial Infarction; High-sensitive; Point of Care; Troponin I; Near-patient test; Heart attack; 99th percentile upper reference limit

Outcome Measures

Primary Outcomes (1)

• Overall 99th percentile URL

  Determine the overall 99th percentile URL of the SpinChip hs-cTnI test using cTnI results obtained from analysis of Li-Heparin whole blood and Li-Heparin plasma samples using the non-parametric method

  1 day

Secondary Outcomes (3)

• Sex-specific 99th percentile URLs

  1 day

• Percentage of measurable values above LoD

  1 day

• Incidence of AEs, ADEs, and DDs

  1 day

Interventions

SpinChip hs-cTnI DIAGNOSTIC_TEST

SpinChip Platform, consisting of the SpinChip hs-cTnI test (self-contained cartridge) and SpinChip Analyzer (instrument).

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

A minimum of 800 healthy subjects with a balanced gender distribution (minimum 400 females and 400 males).

You may qualify if:

• Able and willing to provide signed written informed consent
• years old
• Estimated glomerular filtration rate (eGFR) \> 60 mL/min/1.73 m2 for subjects 18-65 years and \> 50 mL/min/1.73 m2 for subjects \> 66 years
• Haemoglobin A1c (HbA1c) \< 6.5% (\< 48 mmol/mol)
• NT-proBNP (N-terminal prohormone of brain natriuretic peptide) \< 125 ng/L or BNP (brain natriuretic peptide) \< 35 ng/L

You may not qualify if:

• All known cardiovascular or cardiac diseases (evaluated using questionnaire; personal history of acute myocardial infarction (AMI) or other cardiac diseases (angina, stroke, atrial fibrillation, peripheral vascular disease (PVD), deep vein thrombosis (DVT), pulmonary embolism (PE), cardiac valve disease, heart failure)
• Treatment for hyperlipidaemia (medication reported in questionnaire)
• Hypertension (as judged by the investigator) or use of medication for hypertension (medication reported in questionnaire)
• Treatment for diabetes, including dietary treatment (reported in questionnaire)
• Abnormal BMI (body mass index) (\< 18 kg/m2 or \> 35 kg/m2), calculated from data collected during enrolment visit
• Current smokers (reported in questionnaire)
• Major illness or chronic disease that could affect the heart (lung, liver, unstable or nontreated thyroid disease, or autoimmune diseases (evaluated using questionnaire)
• History of cancer within the last 5 years (based on questionnaire) except basal cell carcinoma (in situ)
• Recent acute hospitalisation (within last 3 months, reported in questionnaire)
• Pregnancy (reported in questionnaire)
• Already included in the study

Sponsors & Collaborators

• Aurevia: collaborator
• SpinChip Diagnostics ASA: lead
• CTC Clinical Trial Consultants AB: collaborator

Study Sites (4)

Clinical Trial Consultants (CTC) GoCo

Mölndal, Gothenburg, 431 53, Sweden

Location

CTC Clinical Trial Consultants AB

Uppsala, Uppsala County, 752 37, Sweden

Location

Clinical Trial Consultants (CTC) Ebbepark

Linköping, 58213, Sweden

Location

Phase I-IV Research Unit Karolinska

Solna, 171 64, Sweden

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Li-heparin plasma

MeSH Terms

Conditions

Myocardial Infarction

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Study Officials

• Johan Nilsson, MD/PhD

  CTC Clinical Trial Consultants AB

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 7, 2024
• First Posted: June 17, 2024
• Study Start: May 20, 2024
• Primary Completion: July 22, 2025
• Study Completion: September 19, 2025
• Last Updated: January 26, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

SE (4)